Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Biliary Cancer
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|ClinicalTrials.gov Identifier: NCT00658593|
Recruitment Status : Terminated (due to poor accrual)
First Posted : April 15, 2008
Last Update Posted : December 18, 2012
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether gemcitabine is more effective when given together with or without capecitabine in treating patients with biliary cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with capecitabine to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced, unresectable, or metastatic biliary cancer.
|Condition or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer||Drug: capecitabine Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment||Phase 3|
- To compare overall survival (OS) rates in patients with locally advanced, unresectable or metastatic biliary tree cancer treated with combined gemcitabine hydrochloride and capecitabine vs. gemcitabine hydrochloride alone.
- To compare progression-free survival (PFS) in this patient group.
- To compare response rates (complete response [CR] and partial response [PR]) in this patient group.
- To compare stable disease (SD) rates in this patient group.
- To compare rate of disease control (CR, PR and SD) in this patient group.
- To estimate and compare response duration in this patient group.
- To compare the effects of these treatments on measures of quality of life in this patient group using the EORTC QLQ-C30.
- To compare the nature, severity and frequency of toxicities between the two arms.
OUTLINE: This is a multicenter study. Patients are stratified according to tumour type (cholangiocarcinoma vs. gallbladder or biliary unknown), ECOG performance status (0-1 vs. 2), extent of disease (locally advanced vs. metastatic), and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Gemcitabine hydrochloride and capecitabine): Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II (Gemcitabine hydrochloride alone): Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at 12 weeks after randomization and 4 weeks after completion of study treatment.
After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer|
|Study Start Date :||March 2008|
|Actual Study Completion Date :||January 2011|
- Overall survival
- Progression-free survival
- Response rates (complete response [CR] and partial response [PR])
- Rate of stable disease (SD)
- Rate of disease control (CR, PR, and SD)
- Response duration
- Quality of Life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658593
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|St. Catharines General Hospital at Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 7C6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Study Chair:||Jennifer Knox, MD||Princess Margaret Hospital, Canada|